- Reference: GJ46872
- Job Type: Contract
- Location: Connacht, Galway, Galway City
- Category: Science, Pharmaceutical & Food
Together, we will change healthcare worldwide. Join us in our Mission to alleviate pain, restore health and extend life worldwide. Let’s work together to address the universal healthcare needs and improve patients’ lives, optimize costs and efficiencies, and expand global access. Together, we can make a real difference in the global disparity in care. By providing quality care at the lowest possible cost, we will succeed as a company, and take the future of healthcare Further, Together.
At our Quality Department located in the Galway Business Park, we focus on ensuring that we manufacture products of the highest quality standard for our customers whilst meeting all applicable global regulatory requirements. The Site Quality Lead is directly involved in leading the team to meet these requirements.
You will be responsible for providing oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines. You will provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations and agency guidelines to assure compliance. You will work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines. You will lead audit and inspection preparation, resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of audits. You will co-ordinate and support all legal requests in support of government investigations and litigations. You will ensure the quality assurance programs and policies are maintained and modified regularly. You will facilitate the use of uniform standards and enable best practice sharing fostering the achievement of the company’s mission.
We are looking for a qualified person to degree level 8 in a science, quality or engineering related discipline and desirably with a minimum of seven years relevant experience. You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams. You are experienced in the requirements of global quality system regulations including ISO 13485:2016, U.S FDA QSR and MDSAP requirements, direct audit experience is desirable. You are an excellent communicator – a key responsibility is managing people. which includes: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.
Leadership Expectations provide the framework for what we expect from all employees – outlining the actions and behaviors we must develop and demonstrate in pursuit of our Mission and global growth goals.
We are committed to being experts in what we do, with a clear vision of where we are going and the plan to get there.
■ Demonstrates Global Business Acumen
■ Thinks Critically and Makes Sound Decisions
■ Sets Strategic Direction
We partner with and involve others, knowing that diverse talent, skills, and perspectives lead to better outcomes.
■ Collaborates and Creates Alignment
■ Attracts, Deploys, and Develops Talent
■ Fosters Diversity and Inclusion
We are bold thinkers who create new ideas and bring our best solutions forward to benefit our patients, partners, and customers.
■ Focuses on Patient and Customer
■ Generates Breakthrough Ideas
■ Initiates and Leads Change
We do what we say we are going to do, delivering results with the highest standards.
■ Sets High Standards
■ Instils Operational Excellence
■ Drives Accountability
■ Models Ethical Behavior
- Christopher O'Toole
- Principal Consultant & Team Lead
- 091 706713
- Connect with ChristopherLinkedINEmail